Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions
- Conditions
- Invasive Breast Cancer
- Interventions
- Device: Smart GoggleOther: Cardio-GreenDevice: SPY Elite Imaging systemDevice: Quest near-infrared (NIR) Imaging systemDevice: PDE Imaging systemDevice: Gamma probeOther: Blue Dyes
- Registration Number
- NCT02802553
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of ICG (Cardio-GreenTM), under standard-of-care application conditions.
- Detailed Description
Primary Objective -Positive fluorescence signal in SLNs imaged by the Smart Goggles system.
Secondary Objectives
* Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.
* Comparison of lesions detected by the Smart Goggles vs. lesions detected using SPY/Quest/PDE vs. gold standard of gamma probe and blue dyes.
Exploratory Objectives
-Collection of preliminary data for a future, powered study for lymphatic mapping in breast cancer
Study Design This is an unpowered pilot study to determine the sensitivity of the new Smart Goggles device, for detection of ICG fluorescence in SLNs of breast cancers in a clinical setting. The investigators have chosen to examine ICG as the contrast agent and breast cancer as the clinical target, because this agent is FDA-approved and is regularly used for lymphatic mapping (skin cancers). The study team will be applying ICG for the same length of time as the standard-of-care procedures including radiotracers and blue dyes. The study involves a single visit, lasting \~3-4 hours total. Multiple SLN biopsies will be performed if multiple SLNs are identified.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 2
- Subjects with at least 1 lesion of tumor of the breast
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
- Subjects who have been treated with radiation therapy on the chest.
- Has had previous sentinel lymph node biopsy
- Has a known hypersensitivity to ICG, methylene blue and 99mTc-colloid.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Integrated Imaging Goggles Smart Goggle Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes. Integrated Imaging Goggles PDE Imaging system Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes. Integrated Imaging Goggles Cardio-Green Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes. Integrated Imaging Goggles Quest near-infrared (NIR) Imaging system Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes. Integrated Imaging Goggles SPY Elite Imaging system Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes. Integrated Imaging Goggles Blue Dyes Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes. Integrated Imaging Goggles Gamma probe Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes.
- Primary Outcome Measures
Name Time Method Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the gamma probe and blue dyes gold standard. At the end of the procedure, about 50 minutes Agreement on 6 consecutive participants would occur less than 2% of the time by random chance (p = 0.56 = 0.016). If the two methods agree on all 6 participants, the current protocol will end successfully. However, if the two methods fail to agree on the SLN once among the first 6 participants, enrollment will continue to 25 participants or until a second failed agreement occurs.
- Secondary Outcome Measures
Name Time Method Fluorescence intensity Typically no more than 30 minutes Fluorescence intensity will be compared for the removed lymph nodes between the Smart Goggles and the standard used fluorescent imaging technology. Intensity will be reported in Arbitrary units
·Sensitivity as measured via the ICG accumulation curve At the end of the procedure, about 50 minutes The ICG accumulation curve generated from each device (Smart Goggles vs previously validated fluorescence imaging systems), measured on the same SLN, will be used to characterize the relative sensitivity of the Smart Goggles for ICG detection in vivo.
Specificity as measured via the ICG accumulation curve At the end of the procedure, about 50 minutes The ICG accumulation curve generated from each device (Smart Goggles vs previously validated fluorescence imaging systems), measured on the same SLN, will be used to characterize the relative specificity of the Smart Goggles for ICG detection in vivo.
Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the SPY/Quest/PDE imaging systems. At the end of the procedure, about 50 minutes A commercial imaging system that measures fluorescence output of ICG will be used to measure the near infrared fluorescence in vivo. Measurements are painless and involve no risk to the participant. The measurements are non-contact and recorded by a computer; each measurement is painless and takes 10 seconds. The signal is calibrated against known fluorescence standards, and the relative amount of ICG in a given measurement is interpolated from the standard curve.
Number of samples with ICG detected in biopsy tissue At the end of the procedure, about 50 minutes Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.
Number of removed lymph nodes with cancer cells At the end of the procedure, about 50 minutes Standard histological analyses will be performed on the biopsy specimens. Presence of absence of cancer cells in the removed lymph nodes will serve as the source of specificity.
Number of samples with lymph node detected in biopsy tissue At the end of the procedure, about 50 minutes Confirmation of lymph node tissue within lesions per histologic tissue exam by SLN biopsy.
Number of surgeons who prefer interventional device vs current near-infrared (NIR) cameras At the end of the procedure, about 50 minutes Surgeons preference for using the Googles for ICG detection versus the current near-infrared NIR cameras
Trial Locations
- Locations (1)
Cleveland Clinic, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States